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Quantifying Energetic Demands of Walking for People With Cerebral Palsy

Quantifying Energetic Demands of Walking for People With Cerebral Palsy

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04303078
Enrollment
34
Registered
2020-03-10
Start date
2023-08-15
Completion date
2025-06-17
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy

Keywords

Energetic cost

Brief summary

The purpose of this study is to examine the underlying mechanisms that contribute to high energy costs for people with cerebral palsy (CP) as they walk. The investigators will characterize the cost landscape of children with CP, quantifying the magnitude of cost (net nondimensional oxygen consumption) associated with walking and common sub-tasks of walking, such as supporting and stabilizing the body.

Detailed description

Children with CP use large amounts of energy to walk and move, leading to fatigue and limiting participation. For people with CP the energetic cost of walking is on average over two times higher than typically-developing (TD) peers. This means that for people with CP, walking is as tiring as jogging or climbing stairs. An energetic cost of this magnitude restricts activities of daily living (ADL) and causes exhaustion. While the investigators and many others have sought to reduce these energetic costs through surgical interventions, rehabilitation, orthotics, or other assistive devices, these strategies have failed to result in meaningful reductions in energy. To design strategies that successfully reduce walking costs, the investigators must first understand the underlying mechanisms contributing to elevated cost in people with CP. This basic-science research will provide the foundation to create evidence-based strategies to decrease energy costs, minimize fatigue, and increase quality of life for people with CP and other neurologic injuries.

Interventions

OTHERVarying levels of harness support during walking

Participants will complete a standard gait and motion analysis at varying levels of harness support and stabilization (low, moderate, and high levels).

Sponsors

University of Washington
Lead SponsorOTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Gillette Children's Specialty Healthcare
CollaboratorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
Yes

Inclusion criteria

for Cases: * 8-17 years old * Diagnosed with bilateral cerebral palsy * Gross Motor Function Classification System II * No surgery within the last 9 months * No current baclofen pump or explantation in the last 2 months * No botulinum toxin or phenol injections in the last 2 months * Had a prior gait and motion analysis at Gillette Children's Specialty Healthcare * Participant and caregiver able to speak and read English * Ability to follow instructions Inclusion Criteria for Controls: * 8-17 years old * Participant and caregiver able to speak and read English * Ability to follow instructions

Design outcomes

Primary

MeasureTime frameDescription
Net Nondimensional Oxygen CostBaseline walking trial with harness on (5-minutes) and support walking trials with vertical or lateral support in harness system (5-minutes)Steady-state net nondimensional oxygen consumption while walking on a treadmill. Percent change in oxygen consumption was evaluated between baseline without support and with vertical and lateral support.

Secondary

MeasureTime frameDescription
Three-dimensional Gait Kinematics (Baseline)Initial trial without support (5-minutes)Five features describing kinematics during gait in the harness system without vertical or lateral support collected from marker-based motion capture. Since the harness system differed between vertical and lateral support, baseline kinematics are reported separately for each system in the rows below. The features include (1) median pelvic tilt during the stance phase, (2) peak hip extension, (3) peak knee extension, (4) peak ankle plantarflexion, and (5) the foot progression angle relative to fore-aft direction.
Three-dimensional Gait Kinematics (Support)Trial with maximum support (5-minutes)Five features describing kinematics during gait in the harness system with vertical and lateral support. The features include (1) median pelvic tilt during the stance phase, (2) peak hip extension, (3) peak knee extension, (4) peak ankle plantarflexion, and (5) the foot progression angle relative to fore-aft direction.
Three-dimensional Gait Kinetics (Baseline)Initial trial without support (5-minutes)Three features describing kinetics during gait in the harness system without vertical or lateral support collected from marker-based motion capture and instrumented treadmill for ground reaction forces. Since the harness system differed between vertical and lateral support, baseline kinematics are reported separately for each system in the rows below. The features include (1) peak hip extensor moment, (2) peak knee extensor moment, and (3) peak ankle plantarflexor moment.
Three-dimensional Gait Kinetics (Support)Trial with maximum support (5-minutes)Three features describing kinetics during gait in the harness system with vertical and lateral support. . Since the harness system differed between vertical and lateral support, baseline kinematics are reported separately for each system in the rows below. The features include (1) peak hip extensor moment, (2) peak knee extensor moment, and (3) peak ankle plantarflexor moment.
Passive Joint Range of MotionOne-time research visit (15 minutes)Compare passive joint range of motion (degrees) measured by lower extremity physical exam
Selective Motor ControlOne-time research visit (15 minutes)Selective motor control (0 patterned movement - 2 complete isolated movement)
Lower Extremity StrengthOne-time research visit (15 minutes)Lower extremity strength measures by the manual muscle test (0 no muscle contraction - 5 typical muscle function)

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORKatherine Steele, PhD

University of Washington

PRINCIPAL_INVESTIGATORMichael Schwartz, PhD

Gillette Children's Specialty Healthcare

Participant flow

Recruitment details

Participants were recruited through Gillette Children's via electronic medical record search, flyers, social media postings, and word of mouth at local clinics and community organizations. Recruitment started in the Summer of 2023, after a delay due to a facility flood, and was completed in the Summer of 2025.

Baseline characteristics

Characteristic
Age, Continuous12.8 years
STANDARD_DEVIATION 2.9
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
9 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
1 Participants
Race (NIH/OMB)
Black or African American
1 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
10 Participants
Sex: Female, Male
Female
9 Participants
Sex: Female, Male
Male
15 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 240 / 10
other
Total, other adverse events
0 / 240 / 10
serious
Total, serious adverse events
0 / 240 / 10

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026